臨床研究等提出・公開システム

Date of registration	Oct. 01, 2018
Last modified on	Aug. 10, 2021
Trial ID	jRCT1080224072

Scientific Title	Biomarker study of Atezolizumab with Bevacizumab for Patients with PD-L1 High Expression Non-Small Cell Non-Squamous Cell Lung Cancer
Public Title	Biomarker study of Atezolizumab plus Bevacizumab for PD-L1 High Non-Sq NSCLC

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	National Cancer Center Hospital East
	Address
	Phone Number
	E-mail Address	knosaki@east.ncc.go.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	West Japan Oncology Group
	Address
	Phone Number
	E-mail Address	sawa@wjog.jp

Recruitment Status	completed

Date of First Enrolment		Dec. 06, 2019
Target Sample Size		38
Study Type		Observational
Study Design	Study Design	Accompanying research (Biomarker study)
Study Design	Objective	treatment purpose
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patient enrolled into WJOG10718L (A Phase II Study of Atezolizumab with Bevacizumab for Patients with PD-L1 High Expression Non-Small Cell Non-Squamous Cell Lung Cancer) 2. Written informed consent to biomarker study
	Exclusion Criteria	-
	Minimum Age	20age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		non-small-cell lung cancer
Intervention(s)		investigational material(s) Generic name etc : Atezolizumab with bevacizumab are administrated in WJOG10718L (A Phase II Study of Atezolizumab with Bevacizumab for Patients with PD-L1 High Expression Non-Small Cell Non-Squamous Cell Lung Cancer) INN of investigational material : atezolizumab, bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Atezolizumab: 1200 mg as an IV infusion once every 21 days Bevacizumab: 15 mg/kg as an IV infusion once every 21 days control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety efficacy The correlation between immunological biomarker and the efficacy and safety in WJOG10718L Retrospective analysis to explore the immunological biomarkers (bTMB /LC-SCRUM-IBIS /LC-SCRUM-Liquid) related to the efficacy and safety in WJOG10718L will be performed
Secondary Outcome		other -

Primary Sponsor	Kaname Nosaki (Principal Investigator)
Secondary Sponsor	-

Name of Funding Organization	Chugai Pharmaceutical Co., Ltd
Name of Research Funding	-

Name	IRB, Kyushu Cancer Center
Address	3-1-1 Notame, Minami-ku, Fukuoka
Phone Number	+81-929895222
E-mail Address
Status of Review	Approval
Date of Approval	Nov. 13, 2018

Secondary ID No.	JapicCTI-184133
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
8	Aug. 10, 2021	(this page)	Changes
7	Sept. 10, 2020	Detail	Changes
6	Oct. 11, 2019	Detail	Changes
5	Dec. 17, 2018	Detail	Changes
4	Nov. 07, 2018	Detail	Changes
3	Nov. 07, 2018	Detail	Changes
2	Oct. 01, 2018	Detail	Changes
1	Oct. 01, 2018	Detail

List of change history